Helical Tissue Anchor Device and Delivery System

ABSTRACT

A delivery system for delivering a plurality of helical tissue anchors to repair a wall defect. Coaxially contained within the outer sheath are inner tubular members. The first inner tubular member designed to deploy a first helical tissue anchor, a second inner tubular member designed to deploy a second helical tissue anchor, and a centered inner tubular member contains a cinching mechanism. The two helical tissue anchors are connected to a suture or strap that pull the two helical tissue anchors together to close a tissue defect. A cinching mechanism holds the anchors and tissue defect together and cut the suture or strap.

RELATED APPLICATIONS

This patent application is a non-provisional of Provisional ApplicationNo. 62/367,592 filed on Jul. 27, 2016. This Provisional application isincorporated by reference in its entirety.

FIELD OF THE INVENTION

This present invention relates to an apparatus and method forapproximating or closing tissue defects with anchors that can becontrolled independently of each other. More specifically, the presentinvention relates to a delivery system that deploys two or moreanchoring elements through an endoscope. The device and methods also maybe used for plicating or otherwise reconfiguring tissue and for fixationof tissue or other material to tissue.

BACKGROUND OF THE INVENTION

During a gastrointestinal endoscopic procedure, the operator oftendesires to repair or reconstruct a tear or defect or otherwiseapproximate or fixate tissue or other material by suturing.

Metallic clipping devices were first introduced for the primary purposeof achieving hemostasis of focal gastrointestinal bleeding. Indicationsfor their use have expanded to include closure of perforations andfistulas, securing of catheters and stents, and as a marking device todirect endoscopic, surgical, and radiological therapy, among others.Several endoscopic clipping devices are commercially available. Allconsist of metallic double or triple prongs joined at the proximal end.The prongs of the clip are applied with pressure onto the target tissueand pinched closed by manually squeezing the catheter handle assembly.Clipping devices are limited by a fixed distance and relationshipbetween the prongs.

The fixed distance between the prongs limits the operator's ability toclose defects that exceed this distance, which limits applicability tosmall defects. The fixed relationship between the prongs limits theoperator's ability to position the dip appropriately in relation to thearea in need of treatment. For instance, the clips may not be able toclose a defect that is approached tangentially at a curve or angle.Further, because the proximal ends of the legs are joined, the operatormay not be able to adjust the positioning of one clip prong withoutaffecting the positioning of the second. Positioning also may be limitedbecause the clip may not be properly oriented when it is deployed or theclip may slip out of alignment during application. Finally, the legs ofpresently-used clips must be actuated and anchored at the same time. Ifunequal pressure is applied to the legs during anchoring, closure may besub-therapeutic and scissoring of the legs may occur that can result intissue damage. Presently-used clips are only capable of capturing themucosa and do not penetrate into the deeper wall layers (submucosa andmuscular propria layers).

A suturing device that addresses the limitations of clips is the ApolloOverstitch. This device provides a curved needle movable on an arm topierce tissue and perform tissue approximation and suturing. This deviceis capable of full-thickness (entire bowel wall) tissue capture and theclosure of larger defects, however, the device cannot be deliveredthrough the working (operative) channel of the endoscope and must bepre-mounted on the end of the endoscope. It also involves multiple timeconsuming, technically demanding maneuvers and manipulations. A needremains for an endoscopic tissue closure device which addresses thelimitations of presently-used clips and is capable of full thicknesstissue capture.

The Ovesco “over-the-scope-clip” (OTSC) can achieve full-thicknessclosure of a defect by suctioning tissue into a cap attachment mountedon the end of the endoscope. The clip, mounted on the cap attachment, isreleased by turning a hand wheel, similar to band ligation. The size ofthe defect that can be closed is small, limited by the diameter of thecap attachment. Like the Apollo Overstich, the OTSC must be pre-mountedonto the endoscope prior to use.

Accordingly, it would be desirable to obtain a multiple tissue anchorand delivery system for facilitating the repair of wall defects,plication of tissue, and treatment of lesions delivered through theworking channel of the endoscope.

It would also be desirable to obtain a multiple tissue anchor anddelivery system for repairing wall defects, plicating tissue, andtreating lesions whereby the apparatus and methods have the capabilityto facilitate repairs of defects of any size, plicate tissue of anysize, and treat lesions of any size, with deployment of each anchorindependent of one another under direct endoscopic visualization.

It would also be desirable to obtain a multiple tissue anchor anddelivery system to provide treatment of relatively large perforations,lesions and damage areas under endoscopic visualization.

SUMMARY OF THE INVENTION

The present invention comprises a novel delivery system for deliveringtwo or more helical anchors through an endoscope or colonoscope torepair a wall defect, plicate tissue, or treat a lesion. The deliverysystem comprises an outer sheath tubular member designed to pass throughthe working channel of an endoscope.

Coaxially contained within the outer sheath tubular member are threeindividual inner tubular members; a first inner tubular member beingdesigned to deploy a first helical tissue anchor (sometimes referred toas the “first helical device” hereinafter), a second inner tubularmember being designed to deploy a second helical tissue anchor(sometimes referred to as the “second helical device” hereinafter”), anda third centered inner tubular member containing a retraction member.The first inner tubular member coaxially contains a first reinforcedtubular member that allows rotational manipulation of the first helicaltissue anchor designed to be embedded into the wall tissue. The firstinner tubular member also has a lumen whereby a first control wire iscoaxially enclosed within that functions to release the first helicalanchor. After the first helical tissue anchor is embedded into the walltissues, it is released and the first control wire is retracteddistally. The second inner tubular member coaxially contains a secondreinforced tubular member that allows rotational manipulation of thesecond helical tissue anchor to be embedded into the wall tissue. Thesecond inner tubular member also has a lumen whereby a second controlwire is coaxially enclosed within that functions to release the secondhelical tissue anchor. After the second helical tissue anchor isembedded into the wall tissues, it is released and the second controlwire is retracted distally. Attached to the first helical tissue anchorand to the second helical tissue anchor is a strap or suture mechanismthat is contained within the third central inner tubular member.

The strap or suture member is engaged to the third central inner tubularmember that when moved distally causes the suture member to becometightened between the first and second helical tissue anchors,compelling the two helical tissue anchors together and partially orfully closing the treatment area.

A novel handle assembly can be attached to the distal end of the outersheath tubular member which engages the first inner tubular member, thesecond inner tubular member, and the third inner central tubular member.The handle assembly includes a plurality of rotating thumbwheels, slidebuttons and release mechanisms.

In clinical operation, the access to and visualization of the treatmentarea is first conducted using standard endoscopy techniques. Theclinician passes the multiple helical tissue anchors/inner tubularmember and delivery system through the working channel of the endoscope.

To engage one side of the lesion area, the clinician advances one of thethumb slides forward advancing the first tissue helical anchor and itsdelivery catheter out of the distal end of the outer catheter sheath.The first helical device and its delivery catheter can be visualizedendoscopically. The clinician manipulates the endoscope and maneuversthe first helical tissue anchor and its delivery catheter by sliding theratcheting thumb slide forward to position the first helical tissueanchor against the target site and then rotates the thumbwheel to embedthe first helical device into the mucosal, submucosal or muscle tissueas desired. After the first helical device is satisfactorily embeddedinto the tissue, the clinician retracts the release mechanism to releasethe first helical device. This is accomplished by pulling back on therelease mechanism behind the ratcheting thumb slide. Once the firsthelical device is released, pushing the central button on the thumbslide down releases the thumb slide from the ratchet teeth allowing itto be pulled proximally along with the release mechanism. Retracting thethumb slide back pulls the delivery catheter back into the sheath of thehelical device leaving the first helical device and attached strap orsuture in the tissue.

The clinician then engages the other side of the lesion by advancing theother thumb slide forward to advance the second helical tissue anchorand its delivery catheter out of the distal end of the catheter shaft.The second helical tissue anchor and its delivery catheter can bevisualized endoscopically. The clinician manipulates the endoscope andmaneuvers the second helical device and its delivery catheter toposition the second helical tissue anchor against the target site andthen rotates the thumbwheel to embed the second helical device into themucosal, submucosal, or muscle layer of the wall as desired. After thesecond helical device is satisfactorily embedded into the tissue, theclinician retracts back on the release mechanism to release the secondhelical device. This is accomplished by pulling back on the releasemechanism behind the ratcheting thumb slide. Once the second helicaldevice is released, pushing the central button on the second thumb slidedown releases the thumb slide from the ratchet teeth, allowing it to bepulled proximally. Retracting the thumb slide pulls the deliverycatheter back into the sheath of the helical device leaving the secondhelical device and attached strap or suture in the tissue.

The clinician then advances the central inner tube to pull the twohelical devices and their attached tissues together. A ferrell, bolotie, locking anchor, spring clip or a preformed knot and knot pusherlocks the two helical tissue anchors together to partially or fullyclose the treatment area.

There are two embodiments that perform the same tissue approximationwith the anchor and delivery system, but differ in the inner deliverycatheter mechanisms.

The first embodiment has a single lumen sheath with three elementsrunning throughout its length. Two tubular elements engage theconnector, coupler and anchor components. A third tubular elementfunctions to manipulate the strap or suture held by a wire that extendsproximally through the handle. After delivery of the anchors, the twotubular elements of the delivery systems are retracted out of the sheathand a knot pusher or ferrel is pushed over the third element and sutureor strap tether moving and locking the anchors together closing thetissue opening.

In the second embodiment, the sheath has a multi-lumen configurationthat contains three or four individual lumens that are designed to eachcontain the three elements and one for the suture or strap. Two lumensof the sheath function to operate the helical devices. The third andfourth lumens contains the suture or strap assembly and a lockingmechanism. The third and fourth lumen maybe combined further reducingthe catheters profile. The delivery procedures between the twoembodiments are similar whereby the second embodiment advancement of thethird element is accomplished by advancing the sheath itself. The secondembodiment with independent lumens in the sheath for the suture or strapelement reduces the potential for twisting around the helical devicedelivery elements. The third element with its locking mechanism issimilar between the two embodiments whereby they similarly pull on thesuture or strap closing the tissue opening. After placement of thecatheter tip bringing the tissues together, a handle element is pulledto first pinch and lock the suture or strap element and then to cut it.The delivery system is then removed through the endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the distal end of the catheter systemshowing the multi-lumen catheter showing the first and second innertubular members which correspond to the first and second helical anchorsand a third inner tubular member showing the cinching device and afourth inner tubular member with the suture strap mechanism engaged tothe proximal end of an elongated shaft.

FIG. 2 is a perspective view of the distal end of the helical tissueanchor delivery system showing first helical tissue anchor assemblyprojecting distally outward of the multi-tubular catheter shaft.

FIG. 3 is perspective inner view of the distal end of the helical tissueanchor delivery system showing the first and second anchor assembliesand the suture cinching and excising inner tubular member with themulti-tubular catheter shaft removed.

FIG. 4 is a perspective view of the suture cinching and excising innertubular member having a distal section coaxially engaged to a thirdintermediary inner tubular member where by both are coaxially engaged toan elongated shaft member.

FIG. 5 is a perspective view of the suture cinching and excising innertubular member and third intermediary inner tubular member whereby thedistal cap is retracted causing the suture to become cinched between thedistal cap and the distal section.

FIG. 6 is a perspective view of the suture cinching and excising innertubular member and the third intermediary inner tubular member wherebythe distal and proximal sections have been separated from each other byretraction of the distal cap ball mechanism and wherein retraction ofthe proximal section cuts the sutures or strap.

FIG. 7 is a perspective top view of the proximal handle mechanismshowing the overall design and configuration of channels.

FIG. 8 is a perspective inner view of the proximal handle mechanism withthe top body member removed, showing the components and interaction withtubular members.

FIG. 9 is a perspective skeleton view of components of the proximalhandle mechanism with the top and bottom body members removed andfurther showing the components and interaction with tubular members.

FIG. 10 is a perspective view of the helical tissue anchors and suturedelivery components in a clinical setting whereby a defect in thetissues has been closed by manipulation of the delivery handle controlsand retraction of the sutures attached to the two helical tissue anchorsembedded within the side area of the tissue defect.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the invention, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings and particularly to FIG. 1 which is aperspective view of the present invention 10 which includes a distal endof the catheter system showing the multi-lumen catheter 11, a firstinner tubular lumen 13 and second inner tubular lumen 15 whichcorrespond to the first and second helical tissue anchors and associatedshaft members and third and fourth inner tubular lumens 19 and 27 withthe suture strap and cinching mechanism engaged to the proximal ends ofelongated shaft that travels throughout the length of the multi-lumencatheter and terminates in a connection to the handle mechanism 70.

The multi-lumen catheter can be fabricated from a number of polymericmaterials, such as polytetrafluoroethylene (PTFE), FEP, ETFE, polyvinylchloride (PVC), polyethylene, polypropylene, PEEK, polybutylene,acryaontirile-butadiene-styrene (ABS), rubber modified styrene,polyacetal, polyethylene, graphite or nylon, or a combination of metalcoil or braid encapsulated in the polymeric materials or any combinationthereof. The diameter of the first inner tubular lumen 13 and the secondinner tubular lumen 15 is in the range of 0.25 mm to 1.2 mm, with apreferred diameter of 0.5 mm. The multi-lumen catheter 11 can have alength in the range of 100 to 500 cm depending on the clinicalapplication.

Now referring to FIGS. 2 and 8, coaxially aligned within the first innertubular lumen 13 is a first elongated shaft 114 (See FIG. 8) thattravels throughout the length of the multi-lumen catheter and terminatesin a connection to the handle mechanism 70. The elongated shaft 114 hasa series of components that are designed to have a removable component14 on its distal end. On the distal end of the elongated shaft 114 is afixed engagement member 12 that coaxially removably engages a firstremovable anchor engagement member 14. Not shown is a fork configuredmechanism that extends from the distal end of the first engagementmember 12 to become coaxially inserted into the first removable anchorcoupler member 14. On the surface of each fork configuration member, isa tab that become inserted into the bole in the first removable anchorcoupler member 14. The first connection tab with corresponding hole/tabassembly 17 is used to removably affix the first engagement member 12 tothe first removable anchor coupler member 14.

Attached to the distal end of the first removable anchor engagementmember is first helical tissue anchor 26. First helical tissue anchor 26has two different winds or thread pitch where the coils are in a tightconfiguration 36 on the proximal end and have a relatively looseconfiguration 40 on its distal end. The relatively loose configuration40 is designed to utilize rotational forces to embed the first helicaltissue anchor 26 into the mucosal, submucosal or muscle tissues. It isanticipated by the Applicants that the tight configuration 46 can beappropriately shortened in length to minimize this tight configurationfrom protruding from the treated tissue area. Also, the depth of tissueanchor capture can be adjusted when embedding the first tissue helicalanchor to enable full-thickness tissue closure and full-thicknessplication. Located between the first helical tissue anchor 26 and thefirst removable anchor engagement member 14 is a suture connection area21 whereby a suture strap mechanism 22 is affixed by a series ofrotations around the suture connected area 21. The suture mechanismstrap mechanism 22 is designed to allow proximal section of firsthelical tissue anchor shaft 114, first connector member 12, firstremovable anchor coupler member 14 and first helical tissue anchor 26 torotate without the suture strap mechanism rotating. The diameter of thefirst connection member 12 and the first removable anchor coupler memberis in the range of 0.25 mm to 1.2 mm, with a preferred diameter of 0.5mm. First fixed engagement member 12 and first removable anchorengagement member 14 can be fabricated from metallic materials such asbrass, brass alloys, stainless steel, cobalt chrome alloys, nickeltitanium, copper alloys or polymer suture materials both resorbable andnon-resorbable, such as nylon, polypropylene, polyethylene, Kevlar,polyurethane, lactic acid, polycaprolactone, or metallic materials suchas brass, brass alloys, stainless steel, cobalt chrome alloys, nickeltitanium, copper alloys or any combination thereof, or any combinationthereof or polymeric materials, such as polyvinyl chloride (PVC),polyethylene, polypropylene, PEEK, Ultem, polybutylene,acryaontirile-butadiene-styrene (ABS), rubber modified styrene,polyacetal, polyethylene, graphite, polyurethane or nylon, or anycombination thereof.

The suture strap mechanism 22 can be a mono-strand or multi-strandconfiguration and can be fabricated from a number of polymer suturematerials both resorbable and non-resorbable, such as nylon,polypropylene, polyethylene, Kevlar, polyurethane, lactic acid,polycaprolactone, or metallic materials such as brass, brass alloys,stainless steel, cobalt chrome alloys, nickel titanium, copper alloys orany combination thereof, or any combination thereof or polymericmaterials, such as polyvinyl chloride (PVC), polyethylene,polypropylene, PEEK, polybutylene, acryaontirile-butadiene-styrene(ABS), rubber modified styrene, polyacetal, polyethylene, graphite,polyurethane or nylon, or any combination thereof.

Also shown in FIG. 2 is third inner tubular member cinching mechanism 34and retraction ball mechanism 36 which is engaged to third connectionshaft 54.

Now referring to FIGS. 3 and 8, which show an inner perspective view ofthe distal end of the helical tissue anchor delivery system showing thefirst and second anchor assemblies and the suture cinching and excisinginner tubular member. The first anchor deployment assembly was describedthe paragraph above this paragraph will focus primarily on the secondanchor deployment assembly. Coaxially aligned within the second innertubular lumen 15 is a second elongated shaft 116 that travels throughoutthe length of the multi-lumen catheter and terminates in a connection tothe handle mechanism 70. The second elongated shaft 116 has a series ofcomponents that are designed to have a second removable anchor couplermember removable 16 on its distal end. On the distal end of theelongated shaft 116 is a second fixed engagement member that coaxiallyremovable engages a second removable anchor engagement member 16. Notshown is a fork configured mechanism that extends from the distal end ofthe second engagement member 29 to become coaxially inserted into thefirst removable anchor coupler member 16. On the surface of each forkconfiguration member, is a tab that become inserted into the hole in thesecond removable anchor coupler member 16. The second connection tabwith corresponding hole/tab assembly 18 is used to removably affix thesecond engagement member 29 to the second removable anchor couplermember 16.

Attached to the distal end of the second removable anchor engagementmember is second helical tissue anchor 42. Second helical tissue anchor42 has two different winds or thread pitch where the coils are in atight configuration 46 on the proximal end and have a relatively looseconfiguration 44 on its distal end. The relatively loose configuration44 is designed to utilize rotational forces to embed the second helicalanchor 42 into the mucosal, submucosal or muscle tissues. It isanticipated by the Applicants that the tight configuration 46 can beappropriately shortened in length to minimize this tight configurationfrom protruding from the treated tissue area. Also, the depth of tissuecapture can be adjusted when embedding the second helical tissue anchorto enable full-thickness tissue closure and full-thickness plication.Located between the second helical tissue anchor 42 and the secondremovable anchor engagement member 16 is a second suture connection area23 whereby a suture strap mechanism 22 is affixed by a series ofrotations around the second suture connected area 23. The suturemechanism strap mechanism 22 is designed to allow proximal section ofsecond tissue anchor shaft 116, second connector member 29, secondremovable anchor coupler member 16 and second helical tissue anchor 42to rotate without the suture strap mechanism rotating. Second fixedengagement member 29 and second removable anchor engagement member 16can be fabricated from metallic materials such as brass, brass alloys,stainless steel, cobalt chrome alloys, nickel titanium, copper alloys orpolymer suture materials both resorbable and non-resorbable, such asnylon, polypropylene, polyethylene, Kevlar, polyurethane, lactic acid,polycaprolactone, or metallic materials such as brass, brass alloys,stainless steel, cobalt chrome alloys, nickel titanium, copper alloys orany combination thereof, or any combination thereof or polymericmaterials, such as polyvinyl chloride (PVC), polyethylene,polypropylene, PEEK, polybutylene, acryaontirile-butadiene-styrene(ABS), rubber modified styrene, polyacetal, polyethylene, graphite,polyurethane or nylon, or any combination thereof.

Also shown in FIGS. 3 and 8 are the third suture cinching and excisinginner tubular member 30 of the proximally located single suture strapmechanism 118 in an extended configuration with the third inner tubularcinching mechanism extended out of the distal end of the suture cinchingand excising inner tubular member 30 and with retraction ball mechanism36. The pair of suture strap mechanisms 32 extend out of the thirdsuture cinching and excising inner tubular member 30 and are attached asdescribed above to first and second suture connection areas. The otherend of the pair of suture strap mechanism penetrates a window 50 in thedistal end that extends proximally toward the handle and at a proximallocation (not shown) forming a loop that engages a proximally locatedsingle suture strap mechanism 118 that extends proximally down thecatheter lumen to the handle 70. Also shown is an interference catchingmechanism 28 that is designed to engage the retraction ball mechanism 36and retract the suture cinching and excising tubular member 30proximally back. When the third suture cinching and excising innertubular member 30 is further retracted proximally, the pair of suturestrap mechanisms 32 is cut by the sharp distal end of the window 50 inthe third suture cinching and excising inner tubular member 30.

Now referring to FIG. 4 which shows a perspective view of the suturecinching and excising inner tubular member 30 having a distal sectioncoaxially engaged to a proximal third intermediary inner tubular member20 where by both are coaxially engaged to the distal section of theelongated shaft member 54. The distal end 54 connects to the elongatedshaft 118 and extends the catheter lumen to the handle assembly 70. Onthe proximal end is the third intermediary inner tubular member 20 thatdistally includes a pair of forks 56. The forks are designed to guideinterference catching mechanism 28. The window 50 in the third distalinner tubular member 30 is clearly shown with the pair of suture strapmechanism 32 traveling through the window 50, out the distal end 60which continues to the first suture strap mechanism connection area 21and second suture strap mechanism connected area 23.

Shown in the perspective view of FIG. 5, is the suture cinching andexcising inner tubular member 30 and third intermediary inner tubularmember 20 whereby the distal cap 34 is retracted causing the pair ofsutures strap mechanism 62 to become cinched between the distal cap 34and the distal end of the suture cinching and excising inner tubularmember 30.

In FIG. 6, shown is a perspective view of the suture cinching andexcising inner tubular member 30 and third intermediary inner tubularmember 20 whereby the distal and proximal sections have been separatedfrom each other by retraction of the distal cap ball mechanism 36 andwherein retraction of the proximal section cuts the sutures. Theincising of the suture strap mechanism generally occurs after the firsthelical tissue anchor 26 and second helical tissue anchor 42 have beenembedded into the mucosal tissue layers and the defect in the wall hasbeen closed by biasing the first helical tissue anchor 26 and secondhelical tissue anchor 42 toward each other.

FIG. 7 is a perspective view of the handle mechanism 70 having a body 78that comprises a clam shell design. The clam shell design has a topsection and a bottom section that felicitate the fabrication andplacement of the handle components within the handle mechanism 70. Thehandle mechanism 70 has a pair of thumbwheels 96, 94 for producingrotational forces to the inner tubular members 114, 116 respectively,with distally mounted helical tissue anchors 26, 42. Included is a firstslide button 88 for advancing and retracting the first inner tubularmember 114, and a first release button 84 for disengaging the firsthelical tissue anchor 26. Also included is a second slide button 90 foradvancing and retracting the second inner tubular member 116, and asecond release button 86 for disengaging the second helical tissueanchor 42. Attached and engaged to the distal end of the handle body 78is the proximal end of the outer sheath 102 with strain releasemechanism 100.

The first inner tubular member 114, at the sheath strain relief 100,enters the handle body 78 from its originating distal end whereby theouter surface of the first inner tubular member 114 is engaged to thefirst thumbwheel 96 allowing for rotational movement and embedment ofthe first helical tissue anchor 26. The first inner tubular member 114is further engaged to the first slide mechanism 88 for advancing andretracting the first tubular member 114 within the sheath and formaneuvering its proximal end with first helical tissue anchor 26,towards the desired treatment site. The first release button 84 is alsoengaged to the first inner tubular member's stylus for releasing thefirst helical tissue anchor 26 after embedment in the tissue.

The second inner tubular member 116, at the sheath strain relief, 100enters the handle body 78 from its distal end whereby the outer surfaceof the second inner tubular member 116 is engaged to the secondthumbwheel 94 allowing for rotational movement for embedment of thesecond helical tissue anchor 42. The second inner tubular member 116 isfurther engaged to the second slide mechanism 90 for advancing andretracting the second tubular member 116 within the sheath and formaneuvering its proximal end with second helical tissue anchor 42,towards the desired treatment site. The second release button 86 is alsoengaged to the second inner tubular member's stylus for releasing thesecond helical tissue anchor 42 after embedment in the tissue.

The handle body 78, the pair of thumbwheels 94, 96, the pair of slidebuttons 86, 88 and the pair or release buttons 84, 86 all can befabricated from a number of polymeric materials, such as polyvinylchloride (PVC), polyethylene, polypropylene, PEEK, polybutylene,acryaontirile-butadiene-styrene (ABS), rubber modified styrene,polyacetal, polyethylene, polyurethane or nylon, or any combinationthereof.

FIG. 8 is a perspective top view of the bottom section 106 of the handlemechanism 70 showing the overall design and configuration of channels.In this figure, the upper clam shell component has been removed and abetter view of all the internal components is shown. The handlemechanism 70 is a clam shell design that facilitates the assemblyprocess for placing and locating the various components. The uppersection and lower section of the claim shell design can be attached toeach other using general adhesive, snap fit or screw technology. At theproximal end of the handle mechanism 70 is a proximal retraction member72 with proximal member shaft 74 and proximal retraction finger grips.Positioned in specific locations are the first, second, third and fourthclam shell connection means 104 a, 104 b, 104 c, 104 d. Also positionedin a strategic location is the first and second clam shell alignment tab110 a and 110 b. The third slide button 80 is engaged to springmechanism 108 and the top half of the handle 78 to apply tension to thesuture strap mechanism. The single suture strap mechanism 118, entersfrom the strain relief 100 and is positioned by the alignment bridge 98,and enclosed by the spring mechanism 108 near the its connection to thethird slide button 80. The proximal section of the first inner tubularmember 114 enters from the strain relief 100, is positioned by analignment bridge 98 to the first tissue anchor thumbwheel 96. The outersurface of the first inner tubular member 114 is engaged to the lumen ofthe first tissue anchor thumbwheel 96 by adhesive or press fit such thatrotation of the first tissue anchor thumbwheel imparts a likewiserotational force on the first inner tubular member 114 and onward to thefirst tissue anchor 26. The first inner tubular member 114 terminatesengaged to the first slide button 88. The proximal section of the secondinner tubular member 116 enters from the strain relief 100, ispositioned by an alignment bridge 98 to the second tissue anchorthumbwheel 94. The outer surface of the second inner tubular member 116is engaged to the lumen of the first tissue anchor thumbwheel 94 byadhesive or press fit such that rotation of the first tissue anchorthumbwheel 94 imparts a likewise rotational force on the second innertubular member 116 and onward to the second tissue anchor 42. The secondinner tubular member 116 terminates engaged to the second slide button96.

FIG. 9 is a perspective skeleton view of components of the proximalhandle mechanism with the top and bottom body members removed andfurther showing the main components and interaction with tubularmembers. Exiting the strain relief 100 are the first inner tubularmember 114, the second inner tubular member 116, the cinching member 55and the single suture strap mechanism 118. Also shown is first innertubular member 114 passing through, and attached to, a lumen of thefirst thumbwheel 96 and the second inner tubular member 116 passingthrough, and attached to, a lumen of the second thumbwheel 94. Theterminal end of the first inner tubular member 114 is attached to thefirst slide 88 and the second inner tubular member 116 is attached tothe second slide 90. The single suture strap mechanism 118 passingthrough a spring mechanism 108 and terminates at third slide mechanism80 and the cinching member 55 is attached to the proximal retractionhandle 76.

FIG. 10 is a perspective view of a pair of helical tissue anchors 128,126 and suture delivery components 30 in a clinical setting whereby adefect 124 in intestinal mucosal, submucosal or muscle tissues has beenclosed by manipulation of the delivery handle controls and retraction ofthe sutures attached to the two tissue helical anchors embedded withinthe side area of the mucosal or muscle tissues defect.

The Applicants anticipate that further developments and embodiments fora tissue anchor and delivery device with multiple tissue anchors inseries within a catheter including a specifically designed apparatus todeploy series of anchors (details not shown in the Figures). In thisadditional embodiment, the tissue anchor(s) are deployed within thecatheter in an extended or flat like form, then as they are pushed outof a constraining tube they immediately curl into a circular orhelical-like configuration. Further modifications or embodiments for thetissue anchor device has at least two tissue anchors arranged in serieswithin a catheter with a suture or suture like material affixed to thefirst or distal anchor then threaded through the eyelets of eachfollowing anchor(s). The suture is allowed to slide freely through thefollowing anchors then the suture extends through the catheter and outthe proximal end of the catheter such that the operator can grasp theend of the suture. A sliding crimp tie is positioned between every twoanchors in series along the catheter. Once the first anchor is fired andaffixed to tissue it exits the catheter, suture attached, moving thesecond anchor, with sliding but attached suture to the forward or distalend of the catheter. Once the second anchor is affixed to tissue thesuture material connects these two affixed anchors and a sliding crimptie also exits the catheter following the second anchor. The operatorgrasps the proximal suture end and pulls it with the crimp tie supportedby the distal end of the catheter and slides the tie such that theanchors become close to each other and fixed in this configuration,whereby a defect would be closed. Two, three, four, or any number ofanchors can be deployed in the same manner as described above to close acomplex tissue defect.

Operation

The Operation Steps of the first embodiment for repairing wall defectsand lesions are presented below.

Access and visualize the treatment area using standard endoscopy.

Advance the helical tissue anchor device through the working channel ofthe endoscope.

To engage one side of the treatment site, advance one of the thumbslides forward advancing and locking the first helical device and itsdelivery catheter out of the distal end of the catheter shaft at adesired length. The first helical device and its delivery catheter canbe visualized by the endoscope.

Manipulate the scope and first tissue helical anchor and its deliverycatheter to position the first tissue helical device against the firstattachment target site.

Rotate a first thumbwheel to embed the first tissue helical device intothe mucosal, submucosal or muscle tissue as desired.

Pull back on the first release mechanism to release the first helicaldevice.

Push the central button on the first thumb slide to release the thumbslide allowing it to be pulled proximally.

Retract the thumb slide back, pulling the delivery catheter back intothe sheath of the helical device leaving the first tissue helical deviceattached to the suture strap mechanism embedded into the tissue.

To engage the other side of the lesion, advance and lock the secondthumb slide forward advancing the second helical tissue anchor and itsdelivery catheter out of the distal end of the catheter shaft at adesired length. The second helical tissue device and its deliverycatheter can be visualized by the endoscope.

Manipulate the scope and second helical tissue anchor and its deliverycatheter to position the second tissue helical device against the secondattachment target site.

Rotate the other thumbwheel to embed the second tissue helical deviceinto the mucosal, submucosal or muscle tissue as desired.

Pull back on the second release mechanism to release the second tissuehelical device.

Push the central button on the second thumb slide down to release thethumb slide allowing it to be pulled proximally.

Retract the thumb slide back, pulling the delivery catheter back intothe sheath of the helical device leaving the second tissue helicaldevice attached to the suture strap mechanism embedded into the tissue.

Advance the entire device forward allowing the tensioned suture strapmechanism to pull the suture strap into outer sheath until the twoanchors and the tissue defect walls are pulled together partially orfully closing the tissue defect.

Pull the proximal retraction finger grips back to initially lock thesuture strap into the cinching and excising tubular member.

Continue to pull on the retraction finger grips to cut the suture strapand release the suture cinching and excising inner tubular member fromthe cinching member.

The device can then be removed from the endoscope leaving the tissuedefect partially or fully closed by the cinched anchors.

In another embodiment of the device, the cinching mechanism could be aseparate catheter. In this embodiment, the device is removed from theendoscope once the anchors are placed leaving suture strap mechanism inthe endoscope channel.

By holding the central mandrel fixed and sliding the separate cinchingdevice forward, a cinch, ferrell, bolo tie or spring or knot pushed witha knot pusher is pushed distally moving and locking the two helicalanchors together thus, partially or fully closing the treatment area.

While this invention has been described as having a preferred design,the present invention can be further modified within the spirit andscope of this disclosure. The application is therefore intended to coverany variations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice and the art to which this invention pertains and which fallwithin the limits of the appended claims.

1. A multiple helical anchor and delivery system for repairing walldefects, plicating tissue, and treating lesions or damaged tissue,comprising: a sheath tubular member; a first inner tubular member, saidfirst inner tubular member coaxially contained in said sheath tubularmember, said first inner tubular member having a proximal and a distalend; a second inner tubular member, said second inner tubular membercoaxially contained in said sheath tubular member, said second innertubular member having a proximal and distal end; a third inner tubularmember, said third inner tubular member coaxially contained in a thirdlumen, said third inner tubular member functions to tighten, lock andrelease or cut the strap or suture; a first transition portion, saidfirst transition portion engaged to the distal end of said first innertubular member, said transition portion having a first connector, saidfirst connector having a detachable engagement means that releases thefirst releasable connector; a second transition portion, said secondtransition portion engaged to the distal end of said second tubularmember, said transition portion having a second connector, saidconnector having a detachable engagement means that releases a secondreleasable connector; a first tissue helical anchor; a second tissuehelical anchor; said first tissue helical device removably engaged tothe distal end of said first releasable connector; and said secondtissue helical device removably engaged to the distal end of said secondreleasable connector.
 2. The multiple helical anchor and delivery systemfor repairing wall defects, plicating tissue, and treating lesions ordamaged tissue as recited in claim 1, wherein said first and secondtissue helical anchors have a tight and loose pitch.
 3. The multiplehelical anchor and delivery system for repairing wad defects, plicatingtissue, and treating lesions or damaged tissue as recited in claim 1,wherein said tight pitch of said first and second tissue helical anchorshas a shorter length than said loose pitch.
 4. The multiple helicalanchor and delivery system for repairing wall defects, plicating tissue,and treating lesions or damaged tissue as recited in claim 2, whereinsaid tight pitch of said first and second tissue helical anchors isshortened in length to minimize protruding from a treated tissue area.5. A multiple helical device and delivery system for repairing walldefects, plicating tissue, and treating lesions, comprising: a multilumen sheath tubular member; a first inner tubular member, said firstinner tubular member coaxially contained in one lumen, said first innertubular member having a proximal and a distal end; a second innertubular member, said second inner tubular member coaxially contained ina second lumen, said second inner tubular member having a proximal anddistal end; a third inner tubular member, said third inner tubularmember coaxially contained in a third lumen, said third inner tubularmember functions to tighten, lock and release or cut the strap orsuture; a fourth inner tubular member, said fourth inner tubular membercontains said sutures that travel proximally within said multi-lumentubular member; a first transition portion, said first transitionportion engaged to the distal end of said first inner tubular member,said transition portion having a first connector, said connector havinga detachable engagement means; a second transition portion, said secondtransition portion engaged to the distal end of said second tubularmember, said transition portion having a second connector, saidconnector having a detachable engagement means; a first tissue helicalanchor; a second tissue helical anchor; said first tissue helical anchorremovably engaged to the distal end of said first connector; and saidsecond tissue helical anchor removably engaged to the distal end of saidsecond connector.
 6. The multiple helical device and delivery system forrepairing wall defects, plicating tissue, and treating lesions asrecited in claim 5, wherein said first and second tissue helical anchorshave a tight and loose pitch.
 7. The multiple helical device anddelivery system for repairing wall defects, plicating tissue, andtreating lesions as recited in claim 5, wherein said tight pitch of saidfirst and second tissue helical anchors has a shorter length than saidloose pitch.
 8. The multiple helical device and delivery system forrepairing wall defects, plicating tissue, and treating lesions asrecited in claim 6, wherein said tight pitch of said first and secondtissue helical anchors is shortened in length to minimize protrudingfrom a treated tissue area.
 9. A multiple helical device and deliverysystem for repairing wall defects, plicating tissue, and treatinglesions, comprising: a multi-lumen sheath tubular member; a first innertubular member, said first inner tubular member coaxially contained inone lumen, said first inner tubular member having a proximal and adistal end; a second inner tubular member, said second inner tubularmember coaxially contained in a second lumen, said second inner tubularmember having a proximal and distal end; a third inner tubular member,said third inner tubular member coaxially contained in a third lumen,said third inner tubular member functions to tighten, lock and releaseor cut the strap or suture; a fourth inner tubular member, said fourthinner tubular member contains said sutures that travel proximally withinsaid multi-lumen tubular member; a first transition portion, said firsttransition portion engaged to the distal end of said first inner tubularmember, said transition portion having a first connector, said connectorhaving a detachable engagement means; a second transition portion, saidsecond transition portion engaged to the distal end of said secondtubular member, said transition portion having a second connector, saidconnector having a detachable engagement means; a first tissue helicaldevice, said first tissue anchor residing within one of the catheterlumens in a flat configuration; a second tissue helical device, saidsecond tissue anchor residing within one of the catheter lumens in aflat configuration; said first tissue helical device removably engagedin close proximity to the distal end of said first connector wherebysaid first tissue anchor forming a circular or helical-likeconfiguration when fully deployed; and said second tissue helical deviceremovably engaged in close proximity to the distal end of said secondconnector, whereby said second tissue anchor forming a circular orhelical-like configuration when fully deployed.
 10. The multiple helicaldevice and delivery system for repairing wall defects, plicating tissue,and treating lesions as recited in claim 9, wherein said first andsecond tissue helical anchors have a tight and loose pitch.
 11. Themultiple helical device and delivery system for repairing wall defects,plicating tissue, and treating lesions as recited in claim 9, whereinsaid tight pitch of said first and second tissue helical anchors has ashorter length than said loose pitch.
 12. The multiple helical deviceand delivery system for repairing wall defects, plicating tissue, andtreating lesions as recited in claim 9, wherein said tight pitch of saidfirst and second tissue helical anchors is shortened in length tominimize protruding from a treated tissue area.
 13. A multiple helicaldevice and delivery system for repairing wall defects, plicating tissue,and treating lesions comprising the steps of: accessing and visualizingthe treatment area using standard endoscopes; advancing the tissuehelical anchor through the working channel of the endoscope; attachingto one side of the treatment site by advancing a forward motionmechanism to advance the first anchor and its delivery catheter out ofthe distal end of the catheter shaft; operating and manipulating theendoscope with the first tissue helical anchor and its delivery catheterto engage the tissue helical anchor against the first target site;embedding said first tissue helical anchor into the mucosal, submucosalor muscle tissue; releasing the first tissue helical anchor device;retracting said first delivery catheter back into the sheath; engagingthe other side of the tissue site by advancing the second tissue helicalanchor and it delivery catheter out of the distal end of the cathetershaft; operating and manipulating the scope and second tissue helicalanchor and its delivery catheter to engage the second tissue helicalanchor against the second target site; embedding the second tissuehelical anchor into the mucosal, submucosal or muscle tissue; releasingsaid tissue second helical anchor; retracting said second deliverycatheter back into the sheath; sliding the central tube forward movesthe two anchors together thus, partially or fully closing the treatmentarea: and holding the central tube forward and pulling back on thecentral mandrel locks and cuts the strap or suture into a cinchingmember, ferrell, bolo tie, spring or anchor.
 14. The multiple helicaldevice and delivery system for repairing wall defects, plicating tissue,and treating lesions as recited in claim 13 further comprising the stepof adjusting the depth of tissue capture when embedding said firstand/or second helical anchor.
 15. The multiple helical device anddelivery system for repairing wall defects, plicating tissue wherein asrecited in claim 14, further comprising that adjusting the depth oftissue capture enables both full-thickness tissue closure andfull-thickness plication.
 16. A multiple tissue anchor and deliverysystem for repairing wall defects, plicating tissue, and treatinglesions comprising the steps of: accessing and visualizing the treatmentarea using standard endoscopy; advancing the helical device through theworking channel of the endoscope; engaging one side of the treatmentsite, advance one of the thumb slides forward advancing the firsthelical device and its delivery catheter out of the distal end of thecatheter shaft; manipulating the scope and first helical device and itsdelivery catheter to position the helical device against the firstattachment target site; rotating a first thumbwheel to embed the firsthelical device into the mucosal or muscle tissue as desired; pullingback on the first release mechanism to release the first helical device;pushing the central button on the first thumb slide down to release thethumb slide allowing it to be pulled proximally; retracting the firstthumb slide back, pulling the delivery catheter back into the sheath ofthe helical device leaving the first helical device embedded into thetissue; engaging the other side of the lesion, advance the second thumbslide forward advancing the second helical device and its deliverycatheter out of the distal end of the catheter shaft; manipulating thescope and second helical device and its delivery catheter to positionthe second helical device against the second attachment target site;advancing the sheath forward to move the anchors together, thuspartially or fully closing the tissue defect; pulling or advancing acinching mechanism to lock the suture holding the anchors and tissuewalls in the partially or fully closed position; and cutting the sutureand releasing the cinching mechanism
 17. The multiple tissue anchor anddelivery system for repairing wall defects, plicating tissue, andtreating lesions, as recited in claim 16 further comprising the step ofadjusting the depth of tissue capture when embedding said first and/orsecond helical anchor.
 18. The multiple tissue anchor and deliverysystem for repairing wall defects, plicating tissue, and treatinglesions, as recited in claim 17, further comprising that adjusting thedepth of tissue capture enables both full-thickness tissue closure andfull-thickness plication.